FDA.reportPublic FDA data

ASSI

Primary DI
00841645142164
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.27327
Device description
Castroviejo Ndl Hdl Standard; Str.; W/O Lock
Published
2020-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GZXInstrument, Microsurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645142164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645142164008416451421648416451421640841645142164

GMDN Terms#

Term, Definition table
TermDefinition
Needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
00190776424121MillenniumAvalign Technologies, Inc.GZX2026-08-27
00190776420376MillenniumAvalign Technologies, Inc.GZX2026-08-25
00190776419134MillenniumAvalign Technologies, Inc.GZX2026-08-23
00190776427191MillenniumAvalign Technologies, Inc.GZX2026-08-21
00190776414672MillenniumAvalign Technologies, Inc.GZX2026-08-18
00190776408640MillenniumAvalign Technologies, Inc.GZX2026-08-03
00190776407407MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407414MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776422271MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407322MillenniumAvalign Technologies, Inc.GZX2026-07-28
00190776404093MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404116MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404123MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404130MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404086MillenniumAvalign Technologies, Inc.GZX2026-07-22
00190776400613MillenniumAvalign Technologies, Inc.GZX2026-07-21
00190776403386MillenniumAvalign Technologies, Inc.GZX2026-07-21
00650551006978PMT® SUCTION INSTRUMENTSPMT CORPORATIONGZX2026-07-20
00190776402099MillenniumAvalign Technologies, Inc.GZX2026-07-19
00190776400408MillenniumAvalign Technologies, Inc.GZX2026-07-17
00190776400415MillenniumAvalign Technologies, Inc.GZX2026-07-17
00190776395681MillenniumAvalign Technologies, Inc.GZX2026-07-14
00846159039672SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039689SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039696SCANLAN® ScissorsSCANLAN INTERNATIONAL INCGZX2026-05-27
04250418753395Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27