FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660012458
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Biemer vessel clip
Catalog number
33-774
Device description
Biemer vessel clip, 9.0mm jaw length, 5.0mm jaw opening
Published
2021-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDOApplier, surgical, clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660012458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660012458001906600124581906600124580190660012458

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA sterile, metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

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
DM exempt
true
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
14026704928702WECKTELEFLEX INCORPORATEDGDO2026-08-25
14026704928436WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928443WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928450WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928467WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928474WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928481WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928498WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928504WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928511WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928528WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928535WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928542WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928559WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928566WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928573WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928580WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928597WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928603WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928610WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928627WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928634WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928641WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928658WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928665WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928672WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928689WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928696WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928719WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928726WECKTELEFLEX INCORPORATEDGDO2026-08-21