FDA.reportPublic FDA data

Silver Cup

Primary DI
00810104130714
Brand
Silver Cup
Company
WILLOW INNOVATIONS, INC.
Model
100-00032
Device description
Silver Nursing Cup
Published
2024-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HFSShield, Nipple

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFSShield, NippleGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810104130714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810104130714008101041307148101041307140810104130714

GMDN Terms#

Term, Definition table
TermDefinition
Nipple pad/ring, single-useA device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. It may be in the form of a fabric or cotton pad (commonly known as a nursing pad), a dome-shaped gel (e.g., hydrogel) cover, or a ring. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050917861
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060442520004ElvieEL01 - Celeste2018-05-03
00810104131247Wave, Collection Cups, Tubing and Diaphragm Set, RetailCCDT382026-01-28
00810104131261Wave, Collection Cups, 3pc Adapter Set, ReplacementCCAS392026-01-28
00810104130929Wave, Collection Cups KitPMK202025-12-17
00810104130936 Wave Single Manual Pump KitPMK102025-07-23
00810104130943Willow Sync, Pump KitPEG252025-07-23
00810104130950Wave, Container 5oz, ReplacementRC05112025-07-23
00810104130967Wave, Gasket, 2 pack, RetailRG2P122025-07-23
00810104130974Wave, Flapper Valves, 4 pack, RetailRFL4132025-07-23
00810104130981Wave, Flange 24mm, ReplacementRF24142025-07-23
00810104130998Wave, Single, Tubing Set, RetailRSTS152025-07-23
00810104131001Wave, Handle, ReplacementRHR1162025-07-23
00810104130851Willow Go, 2 Splashguard Containers, 5ozL1GC052025-04-29
00810104130868Willow Go, 2 Splashguard Containers, 7ozL2GC072025-04-29
00810104130899Willow Go Splash Guard CCGSGR2025-04-29
00810104130790Silicone Wearable Breast PumpPP052025-04-28
00810104130875Willow Go, Replacement Container Bowl, 5ozR1GBR52025-04-28
00810104130882Willow Go, Replacement Container Bowl, 7ozR2GBR72025-04-28
05060442520561Elvie Pump Single AMZAEP01-01-N42025-02-11
05060442522077Elvie Stride 2EB01-212025-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978707520081ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520098ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520104ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520111ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520128ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
00735282286810MunchkinMUNCHKIN, INC.HFS2025-02-12
10735282286817MunchkinMUNCHKIN, INC.HFS2025-02-12
09420060202021Silicone Nipple Shields (2pcs)THINK GREEN LIMITEDHFS2024-12-17
09420060202069Breastfeeding Nipple Shield - Orthodontic Teat (Triangle Base)THINK GREEN LIMITEDHFS2024-12-17
09420060202076Breastfeeding Nipple Shield - Orthodontic Teat (Round Base)THINK GREEN LIMITEDHFS2024-12-17
09420060202083BreastFeeding Nipple Shield - Butterfly ShapeTHINK GREEN LIMITEDHFS2024-12-17
09420060202090Flexi Silicone Nipple ShieldsTHINK GREEN LIMITEDHFS2024-12-17
09420060202038Ultra-Thin Silicone Nipple Shields - LTHINK GREEN LIMITEDHFS2024-12-16
09420060202045Ultra-Thin Silicone Nipple Shields - MTHINK GREEN LIMITEDHFS2024-12-16
09420060202052 Breastfeeding Nipple Shield - Round BaseTHINK GREEN LIMITEDHFS2024-12-16
09420060202014Silicone Nipple Shields (2pcs)THINK GREEN LIMITEDHFS2024-12-12
00735282281310MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281327MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281334MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281358MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281317MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281324MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281331MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281355MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282383236MunchkinMUNCHKIN, INC.HFS2024-06-25
00735282383243MunchkinMUNCHKIN, INC.HFS2024-06-25
00735282383984MunchkinMUNCHKIN, INC.HFS2024-06-25
00735282383991MunchkinMUNCHKIN, INC.HFS2024-06-25
10735282383233MunchkinMUNCHKIN, INC.HFS2024-06-25
10735282383240MunchkinMUNCHKIN, INC.HFS2024-06-25