FDA.report

ASSI

Primary DI
00841645112686
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.NHFA15RM8
Device description
Satellight Needle Holder Forceps, 15cm Lg., Rnd. Hdl. 8mm Dia., Ctr. Bal., Cvd. 45' Angle To The Side, Tip 0.6mm Dia.
Published
2023-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841645112686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645112686008416451126868416451126860841645112686

GMDN Terms

TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
055870299
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841645143215ASSIASSI.BPNS243252023-08-18
00841645143222ASSIASSI.BPNS153392023-08-18
00841645142843ASSIASSI.SU632262023-08-11
00841645104988ASSIASSI.ACC1VB2023-08-11
00841645105091ASSIASSI.R1A2023-08-11
00841645105107ASSIASSI.ACC11AB2023-08-11
00841645105176ASSIASSI.DC1VB2023-08-11
00841645107385ASSIASSI.BS18822023-08-11
00841645108412ASSIASSI.005822023-08-11
00841645108474ASSIASSI.158842023-08-11
00841645108498ASSIASSI.16252023-08-11
00841645108542ASSIASSI.16632023-08-11
00841645108573ASSIASSI.16672023-08-11
00841645108634ASSIASSI.17002023-08-11
00841645108665ASSIASSI.17342023-08-11
00841645108696ASSIASSI.17402023-08-11
00841645108733ASSIASSI.17682023-08-11
00841645108771ASSIASSI.18002023-08-11
00841645108795ASSIASSI.18022023-08-11
00841645108856ASSIASSI.18322023-08-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417925MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776417963MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776418045MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776418052MillenniumAvalign Technologies, Inc.GEN2026-03-23
24026704941555PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941562PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941579PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941609PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
00192896122949Deluxe Alligator Grasping ForcepsSONTEC INSTRUMENTS, INC.GEN2026-03-19
04046826492632MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGEN2026-03-19
04046826492649MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGEN2026-03-19
G453FA06160PEAK MEDICALPeak Medical Distribution Inc.GEN2026-03-19
00190776417703MillenniumAvalign Technologies, Inc.GEN2026-03-11
00190776417819MillenniumAvalign Technologies, Inc.GEN2026-03-11
00840329836924Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GEN2026-03-05
04058749036152NAFehling Instruments GmbH & Co. KGGEN2026-03-05
00198506088667ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088674ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088872ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-23
00198506088742ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-23
00190776416713MillenniumAvalign Technologies, Inc.GEN2026-02-20
00810130207350MSIModern Surgical Instruments LLCGEN2026-02-20
B382SD6720680Surgical DirectSurgical Direct, Inc.GEN2026-02-17
B382SD6720690Surgical DirectSurgical Direct, Inc.GEN2026-02-17
00190776416508MillenniumAvalign Technologies, Inc.GEN2026-02-16
B382SD49129280Surgical DirectSurgical Direct, Inc.GEN2026-02-16
B382SD6522210Surgical DirectSurgical Direct, Inc.GEN2026-02-16
B382SD6536480Surgical DirectSurgical Direct, Inc.GEN2026-02-16
03662663129046Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCGEN2026-02-11