FDA.reportPublic FDA data

HK Sterile Super Absorbent Pads Small

Primary DI
00816989020805
Brand
HK Sterile Super Absorbent Pads Small
Company
HK SURGICAL INC.
Model
SPD-S
Catalog number
SPD-S
Device description
HK Sterile Super Absorbent Pads 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
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
00816989020805PrimaryGS10
10816989020802Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816989020805008169890208058169890208050816989020805
1081698902080210816989020802

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816989021468HK Klein Infiltration Pump+KIP-II+KIP-II+2025-09-29
00816989020874"HK Tumescent Infiltration Cannula, (15cm) 6""-12 gauge, Single Use, Box of 10"SU-IC12x15SU-IC12x152020-11-20
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
00816989021161"HK Mercedes Cannula 3mm X 30cm (12"") Luer Lock"HKMER330HKMER3302023-12-21
00816989021178HK Mercedes Cannula 4mm X 25cm Luer LockHKMER425HKMER4252023-12-21
00816989021185"HK Mercedes Cannula 4mm X 30cm (12"") Luer Lock"HKMER430HKMER4302023-12-21
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
00816989021284"HK Spatula Single Hole Cannula 3mm X 15cm (6"") Luer Lock"HKSPA315HKSPA3152023-12-21
00816989021291HK TOL Toledo Cannula 2mm x 15cm Luer LockHKTOL215HKTOL2152023-12-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16931918107936HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918100913HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06
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10810178830173Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830180Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
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