FDA.reportPublic FDA data

ASSI

Primary DI
00841645129479
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.AG79026
Device description
Brand Tendon Tunneling /Passing forceps alligator type, cvd. 25 cm
Published
2020-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645129479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645129479008416451294798416451294790841645129479

GMDN Terms#

Term, Definition table
TermDefinition
Tunnelling forcepsA hand-held manual surgical instrument designed to be used to open a soft tissue plane (tunnelling) and to pull an object, typically a tube implant or other device, back through the tunnel. It is made of metal and typically has an elongated, slender, scissors-like design with two blades that close like jaws and ring handles. It may be used during rib/rib cage internal fixation procedures. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
055870299
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
00841645131991ASSIASSI.FOC178/752020-06-30
00841645119371ASSIASSI.125262020-06-25
00841645119425ASSIASSI.129262020-06-25
00841645103325ASSIASSI.FOAL2682016-09-26
00841645131830ASSIASSI.FOAE1632016-09-26
00841645131847ASSIASSI.FOAE1642016-09-26
00841645131854ASSIASSI.FOAE1652016-09-26
00841645131861ASSIASSI.FOAHL2802016-09-26
00841645131878ASSIASSI.FOAL2602016-09-26
00841645131885ASSIASSI.FOAL2612016-09-26
00841645131892ASSIASSI.FOAL2622016-09-26
00841645131908ASSIASSI.FOAL2662016-09-26
00841645131915ASSIASSI.FOAL2672016-09-26
00841645131922ASSIASSI.FOAL2712016-09-26
00841645131939ASSIASSI.FOC158/62016-09-26
00841645131946ASSIASSI.FOC158/752016-09-26
00841645131953ASSIASSI.FOC158/982016-09-26
00841645131960ASSIASSI.FOC171/62016-09-26
00841645131977ASSIASSI.FOC171/752016-09-26
00841645131984ASSIASSI.FOC171/982016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095832ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00840314252449gSourceGSOURCE LLCGEN2026-10-09
00190776436605MilleniumAvalign Technologies, Inc.GEN2026-10-08
00190776433604MillenniumAvalign Technologies, Inc.GEN2026-10-07
00190776434380MillenniumAvalign Technologies, Inc.GEN2026-10-07
B382SD6713210Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6713290Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432560MillenniumAvalign Technologies, Inc.GEN2026-09-28