FDA.report

Key Surgical Suture Booties

Primary DI
10849771024405
Brand
Key Surgical Suture Booties
Company
KEY SURGICAL, INC.
Model
VB-1315
Device description
Suture Booties, Yellow, Sterile, 3 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

Related Records

Contact Domains

Product Codes

CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849771024405PackageGS15In Commercial Distribution
00849771024408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977102440510849771024405
00849771024408008497710244088497710244080849771024408

GMDN Terms

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

TypeValueUnit
Lumen/Inner Diameter0.062Inch

Sterilization Methods

Method

Contacts

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

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