FDA.report

n/a

Primary DI
00822409110896
Brand
n/a
Company
Ortho Development Corporation
Model
261-1050
Device description
Pegged 4-in-1 A/P Shift Guide
Published
2022-02-25
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

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822409110896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409110896008224091108968224091108960822409110896

GMDN Terms

TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags

DUNS number
876542390
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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