FDA.report

BOSS Instruments

Primary DI
00888515201088
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
77-0916
Catalog number
77-0916
Device description
Graft Cutter, adj depth control 8.75", 7mm width
Published
2024-02-28
Public version status
New
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

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888515201088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515201088008885152010888885152010880888515201088

GMDN Terms

TermDefinition
Bone cutterA strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags

DUNS number
848522678
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
00888515149311BOSS Instruments90-7060P90-7060P2024-12-11
00888515231184BOSS Instruments90-700590-70052024-12-11
00888515231191BOSS Instruments90-700790-70072024-12-11
00888515231207BOSS Instruments90-700990-70092024-12-11
00888515231214BOSS Instruments90-701190-70112024-12-11
00888515231221BOSS Instruments90-701390-70132024-12-11
00888515231238BOSS Instruments90-702090-70202024-12-11
00888515231245BOSS Instruments90-702290-70222024-12-11
00888515231252BOSS Instruments90-702490-70242024-12-11
00888515231269BOSS Instruments90-702690-70262024-12-11
00888515231276BOSS Instruments90-702890-70282024-12-11
00888515231283BOSS Instruments90-703990-70392024-12-11
00888515231290BOSS Instruments90-7039P90-7039P2024-12-11
00888515231306BOSS Instruments90-704090-70402024-12-11
00888515231320BOSS Instruments90-7040P90-7040P2024-12-11
00888515231337BOSS Instruments90-704290-70422024-12-11
00888515231351BOSS Instruments90-7042P90-7042P2024-12-11
00888515231368BOSS Instruments90-704490-70442024-12-11
00888515231382BOSS Instruments90-7044P90-7044P2024-12-11
00888515231399BOSS Instruments90-704690-70462024-12-11

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