FDA.report

ADC®

Primary DI
00634782899660
Brand
ADC®
Company
AMERICAN DIAGNOSTIC CORP
Model
39708
Catalog number
39708
Device description
8" 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
00634782599669PackageGS140In Commercial Distribution
00634782899660PackageGS110In Commercial Distribution
00634782098285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782599669006347825996696347825996690634782599669
00634782899660006347828996606347828996600634782899660
00634782098285006347820982856347820982850634782098285

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
Length8Inch

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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