FDA.reportPublic FDA data

N/A

Primary DI
00822409115143
Brand
N/A
Company
Ortho Development Corporation
Model
613-0007
Device description
Broach, Size 7
Published
2024-04-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409115143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409115143008224091151438224091151430822409115143

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822409131662N/AC-1838-072026-02-05
00822409131679N/AC-1838-082026-02-05
00822409131686N/AC-1838-092026-02-05
00822409131693N/AC-1838-102026-02-05
00822409131709N/AC-1838-112026-02-05
00822409131716N/AC-1838-122026-02-05
00822409131723N/AC-1838-132026-02-05
00822409131730N/AC-1838-142026-02-05
00822409131747N/AC-1838-162026-02-05
00822409131754N/AC-1838-182026-02-05
00822409131761N/AC-1838-202026-02-05
00822409131778N/AC-1839-072026-02-05
00822409131785N/AC-1839-082026-02-05
00822409131792N/AC-1839-092026-02-05
00822409131808N/AC-1839-102026-02-05
00822409131815N/AC-1839-112026-02-05
00822409131822N/AC-1839-122026-02-05
00822409131839N/AC-1839-132026-02-05
00822409131846N/AC-1839-142026-02-05
00822409131853N/AC-1839-162026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862653697AlteonExactech, Inc.MEH2026-05-26
10885862653703AlteonExactech, Inc.MEH2026-05-26
10885862653710AlteonExactech, Inc.MEH2026-05-26
10885862653727AlteonExactech, Inc.MEH2026-05-26
10885862653734AlteonExactech, Inc.MEH2026-05-26
10885862653741AlteonExactech, Inc.MEH2026-05-26
10885862653758AlteonExactech, Inc.MEH2026-05-26
10885862653765AlteonExactech, Inc.MEH2026-05-26
10885862653772AlteonExactech, Inc.MEH2026-05-26
10885862653789AlteonExactech, Inc.MEH2026-05-26
10885862653796AlteonExactech, Inc.MEH2026-05-26
10885862653802AlteonExactech, Inc.MEH2026-05-26
10885862653819AlteonExactech, Inc.MEH2026-05-26
10885862653826AlteonExactech, Inc.MEH2026-05-26
10885862653833AlteonExactech, Inc.MEH2026-05-26
10885862653840AlteonExactech, Inc.MEH2026-05-26
10885862653857AlteonExactech, Inc.MEH2026-05-26
10885862653864AlteonExactech, Inc.MEH2026-05-26
10885862653871AlteonExactech, Inc.MEH2026-05-26
10885862653888AlteonExactech, Inc.MEH2026-05-26
10885862653895AlteonExactech, Inc.MEH2026-05-26
10885862653901AlteonExactech, Inc.MEH2026-05-26
10885862653918AlteonExactech, Inc.MEH2026-05-26
10885862653925AlteonExactech, Inc.MEH2026-05-26
10885862653932AlteonExactech, Inc.MEH2026-05-26
10885862653949AlteonExactech, Inc.MEH2026-05-26
10885862653956AlteonExactech, Inc.MEH2026-05-26
10885862653963AlteonExactech, Inc.MEH2026-05-26
10885862653970AlteonExactech, Inc.MEH2026-05-26
10885862653987AlteonExactech, Inc.MEH2026-05-26