FDA.reportPublic FDA data

HK Sterile Super Absorbent Pads XL

Primary DI
00816989020836
Brand
HK Sterile Super Absorbent Pads XL
Company
HK SURGICAL INC.
Model
SPD-XL
Catalog number
SPD-XL
Device description
HK Sterile Super Absorbent Pads XL
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816989020836PrimaryGS10
10816989020833Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816989020836008169890208368169890208360816989020836
1081698902083310816989020833

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816989021468HK Klein Infiltration Pump+KIP-II+KIP-II+2025-09-29
00816989021437HK Klein TDD PumpKTDDKTDD2024-08-29
00816989021130HK Mercedes Cannula 3mm X 15cm Luer LockHKMER315HKMER3152023-12-21
00816989021147HK Mercedes Cannula 2mm X 15cm Luer LockHKMER215HKMER2152023-12-21
00816989021154HK Mercedes Cannula 3mm X 25cm Luer LockHKMER325HKMER3252023-12-21
00816989021161HK Mercedes Cannula 3mm X 30cm (12") Luer LockHKMER330HKMER3302023-12-21
00816989021178HK Mercedes Cannula 4mm X 25cm Luer LockHKMER425HKMER4252023-12-21
00816989021185HK Mercedes Cannula 4mm X 30cm (12") Luer LockHKMER430HKMER4302023-12-21
00816989021192HK HK-2015-MER+215LL (HK-2015 Mercedes Plus Cannula 2mm x 15cm Luer Lock)HKMER+215HKMER+2152023-12-21
00816989021208HK Mercedes Plus Cannula 3mm X 25cm Luer LockHKMER+325HKMER+3252023-12-21
00816989021215HK Mercedes Plus Cannula 4mm X 25cm Luer LockHKMER+425HKMER+4252023-12-21
00816989021222HK Tri-port Cannula 3mm x 25cm Luer LockHKTRI325HKTRI3252023-12-21
00816989021239HK Tri-port plus Cannula 2mm x 15cm Luer LockHKTRI+215HKTRI+2152023-12-21
00816989021246HK Tri-port plus Cannula 3mm x 25cm Luer LockHKTRI+325HKTRI+3252023-12-21
00816989021253HK Tri-port plus Cannula 4mm x 25cm Luer LockHKTRI+425HKTRI+4252023-12-21
00816989021260HK Spatula Single Hole Cannula 12ga x 15cm Luer LockHKSPA1215HKSPA12152023-12-21
00816989021277HK Spatula Single Hole Cannula 14ga x 15cm Luer LockHKSPA1415HKSPA14152023-12-21
00816989021284HK Spatula Single Hole Cannula 3mm X 15cm (6") Luer LockHKSPA315HKSPA3152023-12-21
00816989021291HK TOL Toledo Cannula 2mm x 15cm Luer LockHKTOL215HKTOL2152023-12-21
00816989021307HK Toledo Cannula 3mm x 25cm Luer LockHKTOL325HKTOL3252023-12-21

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