FDA.reportPublic FDA data

Key Surgical Suture Booties

Primary DI
10849771016899
Brand
Key Surgical Suture Booties
Company
KEY SURGICAL, INC.
Model
VB-1100
Device description
Suture Booties, Red, Sterile, 5 pair/pad; 5 pads/box
Published
2020-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849771016899PackageGS15In Commercial Distribution
00849771016892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977101689910849771016899
00849771016892008497710168928497710168920849771016892

GMDN Terms#

Term, Definition table
TermDefinition
Vascular bootiesA sterile cover, used in pairs, fitted onto the distal working end (the jaws) of artery forceps, vascular clamps, or similar surgical instruments, to provide improved grip for delicate sutures. It is typically tube-like with a closed, rounded tip and composed of radiopaque silicone materials. It is available in various sizes and may be straight or curved. The pair of devices may also be known as "jaw covers" (shods). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter0.062Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771052159NAES50ES502023-01-26
00849771048237NAK-Wire and Steinmann Pin DispenserKI710172025-08-11
00849771049036NAK-Wires and Steinmann PinsKI711312025-08-11
00849771049289NAK-Wires and Steinmann PinsKI711852025-08-11
00849771049500NAK-Wires and Steinmann PinsKI712532025-08-11
00849771048169NAK-Wire and Steinmann Pin DispensersKI710022025-04-30
00849771049012NAK-Wires and Steinmann PinsKI711242025-04-30
00849771049128NAK-Wires and Steinmann PinsKI711612025-04-30
60849771050416Electro LubeEL101EL1012025-04-24
00849771046356K-Wire and Steinmann Pin DispensersKI71042KI710422025-04-16
00849771046363K-Wire and Steinmann Pin DispensersKI71044KI710442025-04-16
00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
00849771046394K-Wire and Steinmann Pin DispensersKI71048KI710482025-04-16
00849771013372Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
00849771048190NAK-Wire and Steinmann Pin DispensersKI710062024-10-03
00849771052562Key Surgical Pipe CleanersPC100CPC100C2024-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896122840Alyea-Babcock Vasectomy ClampSONTEC INSTRUMENTS, INC.GDJ2026-03-19
00190776417574MillenniumAvalign Technologies, Inc.GDJ2026-03-04
00190776417550MillenniumAvalign Technologies, Inc.GDJ2026-02-27
00190776415587MillenniumAvalign Technologies, Inc.GDJ2026-01-28
00190776415235MillenniumAvalign Technologies, Inc.GDJ2026-01-27
00190776415570MillenniumAvalign Technologies, Inc.GDJ2026-01-27
00850037180004USB G2 Detachable Vascular Clamp System - 60mm Straight ArmUSB Medical LimitedGDJ2026-01-07
00850037179886USB G2 Detachable Vascular Clamp System - 40mm Curved Arm SetUSB Medical LimitedGDJ2026-01-06
00850037179893USB G2 Detachable Vascular Clamp System - 40mm Straight ArmUSB Medical LimitedGDJ2026-01-06
00850037179909USB G2 Detachable Vascular Clamp System - Right Angle ArmUSB Medical LimitedGDJ2026-01-06
00850037179916USB G2 Detachable Vascular Clamp System - 60mm Curved ArmUSB Medical LimitedGDJ2026-01-06
00850037179923USB G2 Detachable Vascular Clamp System - 60mm Straight ArmUSB Medical LimitedGDJ2026-01-06
00850037179930USB G2 Detachable Vascular Clamp System - 80mm Curved ArmUSB Medical LimitedGDJ2026-01-06
00850037179947USB G2 Detachable Vascular Clamp System - 94mm Gentle Curved ArmUSB Medical LimitedGDJ2026-01-06
00850037179954USB G2 Detachable Vascular Clamp System - 95mm Straight ArmUSB Medical LimitedGDJ2026-01-06
00850037179961USB G2 Detachable Vascular Clamp SystemUSB Medical LimitedGDJ2026-01-06
00850037179978USB G2 Detachable Vascular Clamp SystemUSB Medical LimitedGDJ2026-01-06
00850037179985USB G2 Detachable Vascular Clamp SystemUSB Medical LimitedGDJ2026-01-06
00850037179992USB G2 Detachable Vascular Clamp System - 93mm Curved ArmUSB Medical LimitedGDJ2026-01-06
03662663126373Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDJ2025-12-03
00190776411169MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411176MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411206MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411251MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776409937MillenniumAvalign Technologies, Inc.GDJ2025-09-08
04059453070975Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-09-01
04059453073891Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-09-01
04059453175069Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-28
04059453136732Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-25
04059453175083Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-25