FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFNCLAMP, NON-ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFNClamp, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660054380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660054380001906600543801906600543800190660054380

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776418472MillenniumAvalign Technologies, Inc.FFN2026-03-25
00190776415747MillenniumAvalign Technologies, Inc.FFN2026-02-04
00840183530341BR Surgical, LLCBR Surgical, LLCFFN2025-09-05
04049047072898GimmiGimmi GmbHFFN2025-04-02
00840183526979BR Surgical, LLCBR Surgical, LLCFFN2024-05-30
00888515048317BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00888515048324BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00888515048362BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00888515326705BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00190776305512MillenniumAvalign Technologies, Inc.FFN2023-11-16
00190776248321AvalignAvalign Technologies, Inc.FFN2023-09-28
00190776248826AvalignAvalign Technologies, Inc.FFN2023-09-28
00190776293840MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
00190776329297MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
00190776329303MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
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