FDA.report

Ambler Surgical

Primary DI
00190660205461
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Lorna-Edna non-perforating towel clamp forceps
Catalog number
34-567
Device description
Lorna-Edna non-perforating towel clamp forceps, 3 1/2'', ring handle
Published
2021-01-04
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
false

Related Records

Contact Domains

Product Codes

CodeName
HXDCLAMP

Product Code Classifications

CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660205461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660205461001906602054611906602054610190660205461

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
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags

DUNS number
015272206
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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