FDA.reportPublic FDA data

SkinPen

Primary DI
00850060751738
Brand
SkinPen
Company
Bellus Medical, LLC
Model
F5SP581
Device description
SkinPen Lift Hydrogel
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850060751738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850060751738008500607517388500607517380850060751738

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
888.372.3982customerservice@crownaesthetics.com

Regulatory Flags#

DUNS number
005677967
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060751028SkinPen Precision EliteREF015F5SP3882024-10-01
00850060751110ProGen PRP EclipseP5PG052PROGEN-A152024-08-28
00850060751158ProGen PRP EclipseP5PG053PROGEN-A302024-08-28
00850035498279SP MicroPen EVO Microneedling CartridgeF5SP2232022-05-25
00863221000323SkinPen Precision Treatment KitF5SP013F5SP0132018-04-09
00850060751004SkinPen Precision EliteREF200F5SP386, F5SP4182024-10-01
00850060751011SkinPen Precision EliteREF201F5SP387, F5SP419, F5SP4542024-10-01
00850060751103ProGen PRP EclipseP5PG0192024-08-28
00850060751141ProGen PRP EclipseP5PG0202024-08-28
00850035498262SP MicroPen EVOF5SP2162022-05-25
00850035498378Progen PRP EclipseTN15MLSINGLEF5PG013.022022-05-09
00850035498385Progen PRP EclipseTN30MLSINGLEF5PG014.022022-05-09
00850060751035SkinPen Precision EliteREF200/REF201F5SP3892024-10-01
00850035498873SkinPen Precision Premium Treatment KitF5SP391F5SP3912023-07-31
00850035498415Progen PRP EclipseF5PG0172022-04-22
00850035498422Progen PRP EclipseF5PG0182022-04-22
00850035498439Progen PRP EclipseF5PG0192022-04-22
00850035498446Progen PRP EclipseF5PG0202022-04-22
10863221000320SkinPen Precision Treatment Kits1F5SP0182018-04-09
20863221000327SkinPen Precision Treatment Kits12018-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970206829191PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206820808kegel Hydrogel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-22
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00860015727336KegelStar Port IncNAE2026-04-27
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000058Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLCNAE2025-06-24
00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00810040134708SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00361554005614GentellGentell, LLCNAE2025-02-14
00361554005638GentellGentell, LLCNAE2025-02-14