FDA.reportPublic FDA data

Scanlan® SURG-I-PAW® Instrument Covers

Primary DI
00846159001105
Brand
Scanlan® SURG-I-PAW® Instrument Covers
Company
SCANLAN INTERNATIONAL INC
Model
1001-74
Catalog number
1001-74
Device description
Scanlan® SURG-I-PAW® Instrument Covers - Blue, 3/10" x 5"/ 8 mmx13 cm (2 - 5" pcs /pkg)
Published
2017-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00846159001105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159001105008461590011058461590011050846159001105

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159039269SCANLAN® ForcepsQ26049-4Q26049-42026-05-26
00846159039276SCANLAN® ForcepsQ26065-4NQ26065-4N2026-05-26
00846159039283SCANLAN® ForcepsQ27036-34Q27036-342026-05-26
00846159039290SCANLAN® ForcepsQ27047-34NQ27047-34N2026-05-26
00846159039306SCANLAN® ClampQ27052-2Q27052-22026-05-26
00846159039313SCANLAN® ClampQ27058-9Q27058-92026-05-26
00846159039320SCANLAN® ForcepsQ27064-4Q27064-42026-05-26
00846159039337SCANLAN® ForcepsQ27080-34NQ27080-34N2026-05-26
00846159039344SCANLAN® ForcepsQ27081-4NQ27081-4N2026-05-26
00846159039351SCANLAN® ClampQ27107-2Q27107-22026-05-26
00846159039368SCANLAN® ClampQ27108-2Q27108-22026-05-26
00846159039375SCANLAN® ClampQ27109-2Q27109-22026-05-26
00846159039382SCANLAN® ClampQ27110-2Q27110-22026-05-26
00846159039399SCANLAN® ForcepsQ27112-34Q27112-342026-05-26
00846159039405SCANLAN® ForcepsQ28011-4Q28011-42026-05-26
00846159039412SCANLAN® ClampQ28016-9Q28016-92026-05-26
00846159039429SCANLAN® ClampQ28018Q280182026-05-26
00846159039436SCANLAN® ClampQ28027-32Q28027-322026-05-26
00846159039443SCANLAN® ForcepsQ28033-4Q28033-42026-05-26
00846159039450SCANLAN® ClampQ28046-2Q28046-22026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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