FDA.report

ASSI

Primary DI
00841645129790
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ATK101526
Device description
Boehler Rongeur Bone Cutting 15cm, Double Action Straight 12mm cutting edge
Published
2020-06-24
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
00841645129790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645129790008416451297908416451297900841645129790

GMDN Terms

TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
00198506091124ELMED INCORPORATEDELMED INCORPORATEDGEN2026-05-26
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00846159039276SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039283SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039290SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039306SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039313SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039320SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039337SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039344SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039351SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039368SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039375SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039382SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039399SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039405SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039412SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039429SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039436SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039443SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039450SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039467SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039474SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039481SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039498SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039504SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039511SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039528SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039535SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039542SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26