FDA.report

Salibag Disposable Pouch for CCD/SLB-L

Primary DI
D24865623206
Brand
Salibag Disposable Pouch for CCD/SLB-L
Company
HAGER WORLDWIDE, INC.
Model
656232
Device description
Protective Hygienic pouches for sensors and conventional films
Published
2022-12-05
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
true

Related Records

Contact Domains

Product Codes

CodeName
EGZHolder, film, x-ray

Product Code Classifications

CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D24865623206PrimaryHIBCC0

GMDN Terms

TermDefinition
Sensor holder, single-useA device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags

DUNS number
009277971
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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