FDA.report

Sklar

Primary DI
30649111122129
Brand
Sklar
Company
SKLAR CORPORATION
Model
96-2929
Device description
TOWEL CLAMP 5 INCHESN-PERF PLAST GRN
Published
2019-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30649111122129PrimaryGS10
00649111122128Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3064911112212930649111122129
00649111122128006491111221286491111221280649111122128

GMDN Terms

TermDefinition
Towel clampA surgical instrument designed to hold together surgical towels and/or drapes and/or other devices, e.g., cables/leads that need securing to the site of intervention, e.g., the towels/drapes surrounding or covering the patient/operating table. It is typically made of high-grade stainless steel and can have a variety sizes and designs, e.g., it can have two blades joined at their midpoint that have ring handles at the proximal end, or it may be a single alpha-shaped part joined at the proximal end, whilst the working end may be sharply-pointed, blunted, fenestrated or have various shaped gripping jaws. It is commonly known as a towel clamp, -forceps, or a -clip. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
006966006
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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50649111081499Sklar Instruments96-26822025-05-29

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