FDA.report

Key Surgical Silicone Clamp Covers

Primary DI
10849771031267
Brand
Key Surgical Silicone Clamp Covers
Company
KEY SURGICAL, INC.
Model
VS-101
Device description
Silicone Clamp Covers, Sterile, Red, 0.14" (3.60mm) x 5", 2/pkg
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
10849771031267PackageGS110In Commercial Distribution
00849771031260PrimaryGS10
00849771043881Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977103126710849771031267
00849771031260008497710312608497710312600849771031260
00849771043881008497710438818497710438810849771043881

GMDN Terms

TermDefinition
Clamp jaw cover, sterileA sterile device used in pairs that are placed/fitted onto the distal working end (the jaws) of surgical instruments (e.g., vascular clamps, haemostats and forceps) to provide improved atraumatic grip and even pressure distribution when clamping an artery or a vein. It is typically a long device designed as a cylindrical tube and made of radiopaque silicone materials; it is available in various sizes. It may also be known as jaw covers. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags

DUNS number
604056226
Device count
2
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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