FDA.report

Key Surgical Plastic Instruments

Primary DI
00849771027096
Brand
Key Surgical Plastic Instruments
Company
KEY SURGICAL, INC.
Model
KS-351
Device description
Plastic Instruments, Straight Towel Clamp, round tip, 5", purple
Published
2020-12-21
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
false

Related Records

Contact Domains

Product Codes

CodeName
HXDClamp

Product Code Classifications

CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849771027096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771027096008497710270968497710270960849771027096

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

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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