FDA.report

Ambler Surgical

Primary DI
00190660054380
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Glassman stomach resection forceps
Catalog number
30-679
Device description
Glassman stomach resection forceps, 10'', angled, 4 1/8'' long atraumatic serrated jaws, ring handle
Published
2021-01-07
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
FFNCLAMP, NON-ELECTRICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FFNClamp, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660054380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660054380001906600543801906600543800190660054380

GMDN Terms

TermDefinition
Pylorus clampA hand-held manual surgical instrument intended for atraumatic compression of the pylorus (the lower muscular opening of the stomach) during a surgical procedure. It is typically made of high-grade stainless steel, is available in various sizes, and has a robust design, e.g., the working end will have strong blades that are flat and broad in profile so that they do not cause trauma to duodenal tissue. The blades are serrated with parallel grooves and/or serrations to provide grip and the handle is also robust to allow the required pressure to be applied by the surgeon. 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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