Hartmann Usa Inc

FDA Filings

This page includes the latest FDA filings for Hartmann Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Hartmann Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Diane Marsilio
• FARMABAN S.A.
• Becky Aldhizer
• ESTERILIZACION S.L

FDA Registration(s)

• Registration Number: 1218946
• FEI Number: 1218946
• Name: HARTMANN USA INC.
• Owner & Operator: PAUL HARTMANN CORP
• Contact Address: 481 Lakeshore PKWY ; Rock Hill SC 29730 US
• Official Correspondent:
  • Diane Marsilio
  • 001-803-9851120-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 481 LAKESHORE PKWY. ; ROCK HILL, SC 29730 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00612553000019 HARTMANN USA, INC.	CollaSorb 1g Powder 906003	2024-03-28
GUDID 20612553013464 HARTMANN USA, INC.	AC-TAPE PLUS 4X5 36/CS	2024-01-24
GUDID 10612553024432 HARTMANN USA, INC.	AC-TAPE 65300000	2024-01-24
GUDID 10612553024395 HARTMANN USA, INC.	AC-TAPE PLUS 64310000	2024-01-24
GUDID 04052199630496 HARTMANN USA, INC.	Zetuvit Plus Sil Bor 17,5x17,5cm P10	2023-03-13
GUDID 04052199602844 HARTMANN USA, INC.	Zetuvit Plus Silicone 20x25cm P10	2023-03-13
GUDID 04052199602806 HARTMANN USA, INC.	Zetuvit Plus Silicone 20x20 cm P10	2023-03-13
GUDID 04052199602769 HARTMANN USA, INC.	Zetuvit P10t Plus Silicone 10x20c	2023-03-13
GUDID 04052199602714 HARTMANN USA, INC.	Zetuvit Plus Silicone 12,5x12,5cm P10	2023-03-13
GUDID 04052199602677 HARTMANN USA, INC.	Zetuvit Plus Silicone 8x8cm P10	2023-03-13
GUDID 04052199580746 HARTMANN USA, INC.	Zetuvit Plus Silicone Border Sacr 18x18	2023-03-13
GUDID 04052199580708 HARTMANN USA, INC.	Zetuvit Plus Silicone Border Heel 25x25	2023-03-13
GUDID 04052199580548 HARTMANN USA, INC.	Zetuvit Plus Silicone Border Oval 12x23	2023-03-13
GUDID 04052199580500 HARTMANN USA, INC.	Zetuvit Plus Silicone Border 20x20cm	2023-03-13
GUDID 04052199580463 HARTMANN USA, INC.	Zetuvit Plus Silicone Border 16x26cm	2023-03-13
GUDID 04052199580425 HARTMANN USA, INC.	Zetuvit Plus Silicone Border 15x15cm	2023-03-13
GUDID 04052199580388 HARTMANN USA, INC.	Zetuvit Plus Silicone Border Sacr 23x23	2023-03-13
GUDID 04052199580340 HARTMANN USA, INC.	Zetuvit Plus Silicone Border Oval 13x15	2023-03-13
GUDID 04052199580104 HARTMANN USA, INC.	Zetuvit Plus Silicone Border 12,5x12,5cm	2023-03-13
GUDID 04052199580067 HARTMANN USA, INC.	Zetuvit Plus Silicone Border 10x10cm	2023-03-13
GUDID 04052199580012 HARTMANN USA, INC.	Zetuvit Plus Silicone Border 8x8cm	2023-03-13
GUDID 04052199578224 HARTMANN USA, INC.	Cosmopor Silicone Island Dressing 14” x 4” / 35cm x 10cm	2023-03-08
GUDID 04052199575957 HARTMANN USA, INC.	Omnifix silicone, 10cmx5m, P1	2022-09-15
GUDID 04052199572475 HARTMANN USA, INC.	Cosmopor silicone 15x8cm P10	2022-09-14
GUDID 04052199572444 HARTMANN USA, INC.	Cosmopor silicone 20x10cm P10	2022-09-14
GUDID 04052199572383 HARTMANN USA, INC.	Cosmopor silicone 7,2x5cm P10	2022-09-14
GUDID 04052199572352 HARTMANN USA, INC.	Cosmopor silicone 10x8cm P10	2022-09-14
GUDID 04052199583594 HARTMANN USA, INC.	SORBALUX ABD PAD ST 3x5 400/CS	2021-12-30
ILG HARTMANN USA INC. [PAUL HARTMANN CORP]	PremierPro Tubular Bandage	2017-08-30
KME HARTMANN USA INC. [PAUL HARTMANN CORP]	Disposable Bedding	2011-06-23
KGX HARTMANN USA INC. [PAUL HARTMANN CORP]	Pro's Choice Adhesive	2010-11-04
KGX HARTMANN USA INC. [PAUL HARTMANN CORP]	AC Tape	2010-11-04
ILH HARTMANN USA INC. [PAUL HARTMANN CORP]	AlumaFoam Splints	2010-11-04
FQM HARTMANN USA INC. [PAUL HARTMANN CORP]	Shur-Band	2010-11-04
FQM HARTMANN USA INC. [PAUL HARTMANN CORP]	REB	2010-11-04
FQM HARTMANN USA INC. [PAUL HARTMANN CORP]	PremierPro Three Layer Compression System	2010-11-04
FQM HARTMANN USA INC. [PAUL HARTMANN CORP]	PremierPro Four Layer Compression System	2010-11-04
FQM HARTMANN USA INC. [PAUL HARTMANN CORP]	Econo-Wrap	2010-11-04
FQM HARTMANN USA INC. [PAUL HARTMANN CORP]	EZe-Band	2010-11-04
FQM HARTMANN USA INC. [PAUL HARTMANN CORP]	Deluxe	2010-11-04
FQM HARTMANN USA INC. [PAUL HARTMANN CORP]	Contex	2010-11-04
EYQ HARTMANN USA INC. [PAUL HARTMANN CORP]	Embrace	2009-02-05
EYQ HARTMANN USA INC. [PAUL HARTMANN CORP]	Dignity Various styles	2009-02-05

Related Finance Registrations

NCAGE Code	39CN9	HARTMANN USA, INC.
CAGE Code	39CN9	HARTMANN USA, INC.
S.A.M. Registration	39CN9 [10137511]	HARTMANN USA, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092915287	Mundra,India -> Charleston, South Carolina	MEDICAL BANDAGE	2809 CTN
2020092941215	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	INCONTINENCE PRODUCTS	1328 CTN
202009294717	Shanghai ,China (Mainland) -> Charleston, South Carolina	GAUZE	1606 CTN
202009294724	Shanghai ,China (Mainland) -> Charleston, South Carolina	BANDAGES	1350 CTN
202009248223	Shanghai ,China (Mainland) -> Charleston, South Carolina	GAUZE	1606 CTN
202009248241	Shanghai ,China (Mainland) -> Charleston, South Carolina	BANDAGES	1350 CTN
2020092326868	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	MEDICAL EQUIPMENT	3596 CTN
2020092326868	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	MEDICAL EQUIPMENT	3596 CTN
2020092326868	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	MEDICAL EQUIPMENT	3596 CTN
2020092326880	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	MEDICAL EQUIPMENT	55 PKG