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HARTMANN USA INC.

Last updated September 17, 2026

Information

Country: US
Address: 481 LAKESHORE PKWY., ROCK HILL, SC, 29730
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1218946
DUNS Number: —

Catalogue (178)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Flex-Band 4 Wing 1200/Cs	46100000	FDA UDI	Class I	Active
Flex-Band Oval 1 1/4 X 1 2400/Cs	46150000	FDA UDI	Class I	Active
ColActive Plus AG 4x4 300/cs	10340000	FDA UDI	U	Active
ColActive Plus 2x2	10160000	FDA UDI	U	Active
PROXIMEL BASIC 5x5 10/BX	15713113	FDA UDI	Class I	Active
Sorbalux Drain Sponge St 4x4 6ply 600/Cs	48800000	FDA UDI	Class I	Active
Co-Lastic Lf Tan 2x5 36/Cs	45930000	FDA UDI	Class I	Active
Novaplus #v5974 St 4x5.5 36/Cs	59740073	FDA UDI	Class I	Active
Reb Lf St 4x10 10/Cs	35410000	FDA UDI	Class I	Active
Sorbalux Non-Adherent St 2x3 2400/Cs	48890000	FDA UDI	Class I	Active
Eze-Band Basic Sterile 2x5 36/cs	15800033	FDA UDI	Class I	Active
Sorbalgon Ag st 10x10cm P10	999611	FDA UDI	U	Active
COLACTIVE PLUS AG 7x7 10/BX	10320000	FDA UDI	U	Active
Deluxe Lf St 3x5.5 20/Cs	27300000	FDA UDI	Class I	Active
Flexicon St 3x4.1 96/Cs	19300000	FDA UDI	Class I	Active
Reb Lf St 6x10 10/Cs	35610000	FDA UDI	Class I	Active
ColActive Plus Powder Wound Filler	10160001	FDA UDI	U	Active
Novaplus Esmark V1842 4x12 20/Cs	18420073	FDA UDI	Class I	Active
Reb Lf St 3x5 10/Cs	34300000	FDA UDI	Class I	Active
Conco Conforming 2x4.1 St 96/Cs	81200000	FDA UDI	Class I	Active
PROXIMEL AG SILICONE DRESSING 4x4 10/BX	15200000	FDA UDI	U	Active
PROXIMEL BASIC 9x9 5/BX	15713116	FDA UDI	Class I	Active
Flexicon St 4x4.1 96/Cs	19400000	FDA UDI	Class I	Active
Proximel Silicone Dressing Large Sacral	14700000	FDA UDI	Class I	Active
Flex-Band Sm Fingertip 2 X 1 3/4 2400/Cs	46200000	FDA UDI	Class I	Active
Eze-Band Basic Sterile 6x5 36/cs	15800036	FDA UDI	Class I	Active
PROXIMEL NON BORDER 4x5 10/BX	15713101	FDA UDI	Class I	Active
Ac Tape Plus 2x5 72/Cs	64210000 AC TAPE PLUS 2X5 72/CS	FDA UDI	Class I	Active
Shur-Band St 3x5 10/Cs	59930000	FDA UDI	Class I	Active
PROXIMEL AG SILICONE DRESSING 3x3 10/BX	15100000	FDA UDI	U	Active
CollaSorb 1g Powder	906003	FDA UDI	U	Active
Esmark 4x9 St 20/Cs	18410000	FDA UDI	Class I	Active
Pro's Choice 3x7.5 16/Cs	64730000	FDA UDI	Class I	Active
Flexicol 4x4 10/Bx	48610000	FDA UDI	Class I	Active
PROXIMEL AG SILICONE DRESSING 6x6 5/BX	15300000	FDA UDI	U	Active
Deluxe Lf St 4x11 20/Cs	28400000	FDA UDI	Class I	Active
Reb Lf St 4x5 10/Cs	34400000	FDA UDI	Class I	Active
Pro's Choice 2x7.5 24/Cs	64720000	FDA UDI	Class I	Active
Co-Lastic Lf Tan 2x5 36/Cs	45920000	FDA UDI	Class I	Active
Eze-Band Basic Sterile 3x5 36/cs	15800034	FDA UDI	Class I	Active
Sorbalgon Ag st 2g/30cm P5	999609	FDA UDI	U	Active
ColActive Plus Powder Ag Wound Filler	10160002	FDA UDI	U	Active
Ac-Tape	65300000 AC-TAPE TPK 3X5 16/CS	FDA UDI	Class I	Active
Sorbalux Iv Sponge St 2x2 6ply 1400/Cs	48810000	FDA UDI	Class I	Active
PROXIMEL BASIC NON-BORDER 6x6 5/BX	15713108	FDA UDI	Class I	Active
Sterilux Gz Sponge St 2x2 8ply 3000/Cs	56880000	FDA UDI	Class I	Active
Sorbalux Abd Pad St 8x10 320/Cs	48720000	FDA UDI	Class I	Active
ECONOLUX GZ 14, 5tex ST 2X2 8P (30x50*P2)	416103	FDA UDI	Class I	Active
Esmark 3x9 St 20/Cs	18310000	FDA UDI	Class I	Active
Sterilux Bulky Gz N-St 4.5x4.1 100/Cs	83400000	FDA UDI	Class I	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 14, 2012	Z-1858-2012	—	terminated	Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
May 14, 2012	Z-1857-2012	—	terminated	Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Feb 11, 2011	Z-1866-2011	—	terminated	Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. Consignees were notified by letter on/about 02/11/2011. They were advised to examine their inventory and not to use any of the affected product and to return it to Paul Hartmann. A response form was included to be completed and returned to Paul Hartmann. They were further instructed to pass the no