FDA.reportPublic FDA data

n/a

Primary DI
00822409064410
Brand
n/a
Company
Ortho Development Corporation
Model
662-3045
Device description
Offset Adapter Alignment Template
Published
2020-08-10
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409064410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409064410008224090644108224090644100822409064410

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. 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
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 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

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Primary DI, Brand, Company table
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00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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