BIOSEAL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2027062	2027062	BIOSEAL	1	N	2026-01-01	167 WEST ORANGETHORPE AVE. PLACENTIA CA US 92870
3043620414	3043620414	Bioseal	1	N	2026-01-01	801 Industrial Blvd Ste 100 Grapevine TX US 76051

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
34742	1117764780	K893814	SURGICAL INSTRUMENT KIT, DISPOSABLE	LRO	1989-08-10
348215	1117764780	K893814	SURGICAL INSTRUMENT KIT, DISPOSABLE	LRO	1989-08-10
34742	1309471349	K882712	STICK SPONGE	EFQ	1988-08-03
34742	1957424290	K882708	GAUZE SPONGE, X-RAY DETECTABLE	GDY	1988-08-03
34742	1205351986	K882707	GAUZE PACKING, X-RAY DETECTABLE	GDY	1988-08-03
34742	1529164951	K882696	DERMICEL, MONTGOMERY STRAP	NAD	1988-08-26
34742	1332126698	K882695	RUBBER BAND, STERILE	ECI	1988-10-13
34742	1059067784	K882694	FIXATION DEVICE, TRACH TUBE	CBH	1988-08-15
34742	1501682447	K180937	Graftgun Universal Graft Delivery System	FMF	2018-05-10
34742	1892256325	K170675	Graftgun Universal Graft Delivery System	FMF	2017-07-19
34742	1009175923
34742	1012738508
34742	1017764756
34742	1022957253
34742	1029497239
34742	1039635897
34742	1041148545
34742	1041358152
34742	1047712531
34742	1051634750
34742	1058258396
34742	1087974779
34742	1092509283
34742	1093089223
34742	1104164245
34742	1115779220
34742	1120009715
34742	1129840845
34742	1145750085
34742	1153210605
34742	1162685660
34742	1170545433
34742	1174186770
34742	1174366357
34742	1183332345
34742	1190092951
34742	1190982312
34742	1195416447
34742	1204075405
34742	1215692133
34742	1215873934
34742	1222354224
34742	1227562268
34742	1251145855
34742	1258158764
34742	1263414410
34742	1281367399
34742	1282242016
34742	1283070628
34742	1297604335
34742	1300548735
34742	1312972013
34742	1325966674
34742	1329893730
34742	1330176593
34742	1333666767
34742	1378888340
34742	1384811709
34742	1398737854
34742	1402945965
34742	1408145031
34742	1412850097
34742	1428600742
34742	1429339681
34742	1434308258
34742	1439969684
34742	1460833344
34742	1473076262
34742	1483006335
34742	1487588659
34742	1495686463
34742	1505764880
34742	1509758072
34742	1528123537
34742	1530245894
34742	1536346032
34742	1537341997
34742	1550720800
34742	1554175584
34742	1560438698
34742	1565217845
34742	1569137768
34742	1578254919
34742	1596899431
34742	1601712278
34742	1602529917
34742	1606015289
34742	1611082193
34742	1645566931
34742	1649055073
34742	1650269073
34742	1661425049
34742	1662794575
34742	1668924667
34742	1685550206
34742	1685973949
34742	1709471355
34742	1720848364
34742	1729486979
34742	1736327597
34742	1739743689
34742	1742113449
34742	1745030366
34742	1748408744
34742	1755924058
34742	1759133544
34742	1762675625
34742	1763083859
34742	1774826028
34742	1784529711
34742	1791580071
34742	1793614769
34742	1793873227
34742	1801211401
34742	1824248613
34742	1827955065
34742	1837973916
34742	1840916369
34742	1845626232
34742	1847445923

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FMF	2	2018-05-10
LRO	2	1989-08-10
GDY	2	1988-08-03
ECI	1	1988-10-13
NAD	1	1988-08-26
CBH	1	1988-08-15
EFQ	1	1988-08-03

PMN#

SURGICAL INSTRUMENT KIT, DISPOSABLE
1989-08-10
BIOSEAL
RUBBER BAND, STERILE
1988-10-13
BIOSEAL
DERMICEL, MONTGOMERY STRAP
1988-08-26
BIOSEAL
FIXATION DEVICE, TRACH TUBE
1988-08-15
BIOSEAL
TONSIL SPONGE, X-RAY DETECTABLE, W/STRING
1988-08-03
BIOSEAL
STICK SPONGE
1988-08-03
BIOSEAL
INTESTINAL SPONGES
1988-08-03
BIOSEAL
GAUZE SPONGE, X-RAY DETECTABLE
1988-08-03
BIOSEAL
GAUZE SPONGE 12PLY
1988-08-03
BIOSEAL
GAUZE PACKING, X-RAY DETECTABLE
1988-08-03
BIOSEAL

GUDID#

Bioseal Inc. - Reston Foam
BIOSEAL
2023-09-20
Bioseal Inc. - Foam Padding
BIOSEAL
2023-09-20
Bioseal Inc. - Foam
BIOSEAL
2023-09-20
Bioseal Inc. - "Foam Padding 1/2"" Thick"
BIOSEAL
2023-09-20
Bioseal Inc. - Polyester Padding
BIOSEAL
2023-09-20
Bioseal Inc. - Reston Foam
BIOSEAL
2023-09-20
Bioseal Inc. - Polyester Padding
BIOSEAL
2023-09-20
Bioseal Inc. - LIPO Foam
BIOSEAL
2023-09-28
Bioseal Inc. - Pink Foam
BIOSEAL
2023-09-28
Bioseal Inc. - Foam Padding
BIOSEAL
2023-09-28
Bioseal Inc. - Foam Padding
BIOSEAL
2023-09-18
Bioseal Inc. - Reston Foam
BIOSEAL
2023-09-28
Bioseal Inc. - Foam Padding
BIOSEAL
2023-09-28
Bioseal Inc. - Foam Padding
BIOSEAL
2023-09-28
Bioseal Inc. - Stethoscope
BIOSEAL
2023-10-05
Bioseal Inc. - Pediatric Stethoscope
BIOSEAL
2023-10-05
Bioseal Inc. - Neonatal Stethoscope
BIOSEAL
2023-10-05
Bioseal Inc. - Neonatal Metallic Raspberry
BIOSEAL
2023-10-05
Bioseal Inc. - Fox Dermal Curette
BIOSEAL
2024-01-10
Bioseal Inc. - Dermal Curette Sgl-ended Handle
BIOSEAL
2024-01-10
Bioseal Inc. - Fox Dermal Curette
BIOSEAL
2024-01-10
Bioseal Inc. - Dermal Curette Sgl-ended Handle
BIOSEAL
2024-01-10
Bioseal Inc. - Foil Strip
BIOSEAL
2023-09-25
Bioseal Inc. - Foil Sheets
BIOSEAL
2023-09-25
Bioseal Inc. - Geniometer Baseline
BIOSEAL
2023-10-02
Bioseal Inc. - EZ Read Jamar
BIOSEAL
2023-10-05
Bioseal Inc. - "STERILE 6"" Ruler"
BIOSEAL
2023-10-02
Bioseal Inc. - Measuring Tape
BIOSEAL
2023-10-02
Bioseal Inc. - Measuring Tape
BIOSEAL
2023-10-03
Bioseal Inc. - Measuring Tape
BIOSEAL
2023-10-03
Bioseal Inc. - Measuring Tape Plastic
BIOSEAL
2023-10-03
Bioseal Inc. - Measuring Tape Plastic
BIOSEAL
2023-10-03
Bioseal Inc. - Measuring Tape Plastic White
BIOSEAL
2023-10-03
Bioseal Inc. - "Measuring Tape 36"""
BIOSEAL
2023-10-03
Bioseal Inc. - Measuring Tape Plastic
BIOSEAL
2023-10-03
Bioseal Inc. - Measuring Tape Plastic
BIOSEAL
2023-10-03
Bioseal Inc. - "Measuring Tape 36"""
BIOSEAL
2023-10-02
Bioseal Inc. - Danz Corneal Shield Small
BIOSEAL
2024-01-29
Bioseal Inc. - Danz Corneal Shield Large
BIOSEAL
2024-01-29
Bioseal Inc. - Danz Corneal Shield Medium
BIOSEAL
2024-01-29

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