FDA.report

Fine Osteotomy Reusable Surgical Instruments Set

Primary DI
00688346000016
Brand
Fine Osteotomy Reusable Surgical Instruments Set
Company
Laboratoires Bodycad Inc
Model
025-002
Catalog number
025-002
Published
2020-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00688346000016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00688346000016006883460000166883460000160688346000016

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
202981171
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00688346000047Fine Osteotomy system - Proximal tibia015-410-001015-410-0012020-05-20
00688346000078Fine Osteotomy system - Distal femur015-330-001015-330-0012020-05-20
00688346000108Fine Osteotomy implants - Distal femur015-330-101015-330-1012020-05-20
00688346000122Fine Osteotomy implants - Proximal tibia015-410-101015-410-1012020-05-20
00688346000283Fine Osteotomy system - Distal femur015-330-002015-330-0022020-05-20
00688346000290Fine Osteotomy system - Distal femur015-330-003015-330-0032020-05-20
00688346000320Fine Osteotomy system - Distal femur015-330-006015-330-0062020-05-20
00688346000337Fine Osteotomy system - Distal femur015-330-007015-330-0072020-05-20
00688346000344Fine Osteotomy implants - Distal femur015-330-102015-330-1022020-05-20
00688346000351Fine Osteotomy implants - Distal femur015-330-103015-330-1032020-05-20
00688346000368Fine Osteotomy implants - Distal femur015-330-104015-330-1042020-05-20
00688346000375Fine Osteotomy implants - Distal femur015-330-105015-330-1052020-05-20
00688346000382Fine Osteotomy implants - Distal femur015-330-106015-330-1062020-05-20
00688346000399Fine Osteotomy implants - Distal femur015-330-107015-330-1072020-05-20
00688346000405Fine Osteotomy system - Proximal tibia015-410-002015-410-0022020-05-20
00688346000412Fine Osteotomy system - Proximal tibia015-410-003015-410-0032020-05-20
00688346000429Fine Osteotomy system - Proximal tibia015-410-004015-410-0042020-05-20
00688346000436Fine Osteotomy system - Proximal tibia015-410-005015-410-0052020-05-20
00688346000443Fine Osteotomy system - Proximal tibia015-410-006015-410-0062020-05-20
00688346000450Fine Osteotomy system - Proximal tibia015-410-007015-410-0072020-05-20

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