FDA.report

ADC®

Primary DI
00634782899677
Brand
ADC®
Company
AMERICAN DIAGNOSTIC CORP
Model
39712
Catalog number
39712
Device description
12" Goniometer 360 Degree
Published
2020-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KQWGoniometer, Nonpowered

Product Code Classifications

CodeDeviceSpecialtyClass
KQWGoniometer, NonpoweredOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782599676PackageGS15In Commercial Distribution
00634782800055PackageGS110In Commercial Distribution
00634782899677PackageGS120In Commercial Distribution
00634782098292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782599676006347825996766347825996760634782599676
00634782800055006347828000556347828000550634782800055
00634782899677006347828996776347828996770634782899677
00634782098292006347820982926347820982920634782098292

GMDN Terms

TermDefinition
Manual goniometerA non-powered, manually-operated measuring device, graduated in degrees (e.g., from 0 to 360 degrees), designed to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. It is typically used by rheumatologists, physiotherapists, orthopaedists and general practitioners to evaluate joint movement (e.g., ankle, finger, knee, shoulder or spine) before and after a medical/surgical intervention. It may be made of plastic or stainless steel and is available in various designs (e.g., protractor-like with pivoting arms, dial-like with twin rotating dials). This is a reusable device.

Device Sizes

TypeValueUnit
Length12Inch

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
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
false

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