FDA.report

HK Sterile Super Absorbent Pads X-Small

Primary DI
00816989020799
Brand
HK Sterile Super Absorbent Pads X-Small
Company
HK SURGICAL INC.
Model
SPD-XS
Catalog number
SPD-XS
Device description
HK Sterile Super Absorbent Pads X-Small
Published
2017-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816989020799PrimaryGS10
10816989020796Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816989020799008169890207998169890207990816989020799
1081698902079610816989020796

GMDN Terms

TermDefinition
Absorbent wound compression padA non-sterile rolled strip of fabric material (e.g., non-woven polyester) intended to be applied around a wound (e.g., venous stasis ulcer of the leg) as a supplemental padded layer for a pressure bandage, primarily to help evenly distribute pressure and absorb exudates during the compression treatment of the wound. It is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
949-369-0101hkinfo@hksurgical.com

Regulatory Flags

DUNS number
106885259
Device count
48
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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