FDA.report

Scanlan® SURG-I-PAW® Instrument Covers

Primary DI
00846159028966
Brand
Scanlan® SURG-I-PAW® Instrument Covers
Company
SCANLAN INTERNATIONAL INC
Model
1001-74B
Catalog number
1001-74B
Device description
Scanlan® SURG-I-PAW® Instrument Covers - Blue, 3/10" x 5"/ 8 mm x13 cm, BNS (20 per pkg)
Published
2018-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00846159028966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159028966008461590289668461590289660846159028966

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.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags

DUNS number
023055619
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
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00846159035926SCANLAN® Forceps4004-1574004-1572025-11-13
00846159036190SCANLAN® Minimally Invasive Instrument9009-917K9009-917K2025-11-13
00846159036114SCANLAN® Minimally Invasive Instrument9009-2199009-2192025-09-18
00846159036138SCANLAN® Minimally Invasive Instrument9209-2889209-2882025-09-18
00846159036398SCANALN® Needle Holder6006-56-3N6006-56-3N2025-06-09
00846159011944SCANLAN® Titanium Neuro Forceps3003-154-33003-154-32025-05-29
00846159012002SCANLAN® Titanium Neuro Forceps3003-158-33003-158-32025-05-29
00846159012040SCANLAN® Titanium Neuro Forceps3003-159-33003-159-32025-05-29
00846159012767Scanlan Titanium Bayonet Forceps3003-8403003-8402025-05-29
00846159012798SCANLAN® Titanium Forceps3003-843N3003-843N2025-05-29
00846159013733SCANLAN® Forceps4004-97-3A4004-97-3A2025-05-29
00846159014907SCANLAN® Instruments9009-3609009-3602025-05-29
00846159033229SCANLAN® Neuro Instruments3003-8413003-8412025-05-29
00846159036350SCANLAN® 7007-256-5SC2 7007-256-5SC22025-05-08
00846159036367SCANLAN®7007-252-5SC27007-252-5SC22025-05-08
00846159012576SCANLAN® Titanium Forceps3003-904N3003-904N2025-01-31
00846159012774SCANLAN® Neuro Instruments3003-841N3003-841N2025-01-31
00846159023053SCANLAN® Minimally Invasive Instrumentation9009-360N-12C9009-360N-12C2025-01-31
00846159036251SCANLAN® Titanium Neuro Forceps3003-154-3N3003-154-3N2025-01-31
00846159036268SCANLAN® Titanium Neuro Forceps3003-158-3N3003-158-3N2025-01-31

Other Devices Sharing Product Codes

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