FDA.reportPublic FDA data

ASSI

Primary DI
00841645128021
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.AG404626
Device description
"Ballenger Swivel Knife, 19.5cm (7 3/4""),Bayonet, 3mm Wide"
Published
2020-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645128021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645128021008416451280218416451280210841645128021

GMDN Terms#

Term, Definition table
TermDefinition
Cartilage knifeA hand-held manual surgical instrument designed for cutting, shaving or shaping cartilage during a surgical intervention. It is typically a one-piece instrument with a sharp, single-edged, cutting blade at the distal end which is normally very long, similar in shape to a scalpel blade, and may vary in length and size; it has a handle at the proximal end. It is normally made of high-grade stainless steel. Also known as a chondrotome, a cartilage knife can also be used in pathology procedures. This is a reusable device.

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
00198506091155ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091162ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091186ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091193ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091223ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
14250368820892Soft CliP HookHeinz Kurz GmbHLRC2026-05-21
14250368861437Trocar HandleHeinz Kurz GmbHLRC2026-05-21
14250368862007Cartilage PunchHeinz Kurz GmbHLRC2026-05-21
00198506090790ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-15
00198506090752ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
00198506090769ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
00190776421366MillenniumAvalign Technologies, Inc.LRC2026-05-05
00198506090479ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-05
00190776420758MillenniumAvalign Technologies, Inc.LRC2026-04-30
00190776420871MillenniumAvalign Technologies, Inc.LRC2026-04-30
00198506090387ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-30
00198506090394ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-30
00757770535620Bausch + LombBausch & Lomb IncorporatedLRC2026-04-30
00198506090318ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-28
00198506090257ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-21
00198506090288ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-21
00190776419950MillenniumAvalign Technologies, Inc.LRC2026-04-15
00190776419578MillenniumAvalign Technologies, Inc.LRC2026-04-14
00190776419585MillenniumAvalign Technologies, Inc.LRC2026-04-14
00190776418977MillenniumAvalign Technologies, Inc.LRC2026-04-13
00198506089954ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-03
00198506089497ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089824ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089886ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089909ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02