FDA.reportPublic FDA data

SURGICAL DIRECT, INC.

Matched from indexed company URL: Surgical Direct, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036874893003687489SURGICAL DIRECT, INC.1Y2026-01-01811 Harley Strickland Blvd Orange City FL US 32763

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B382S28531030Surgical Direct - Mendez Lasik Forceps, Spatulated Jaw, Smooth Tips, Vaulted Shaft, Three Hole Handle+1 (800) 519-3293info@surgicaldirect.com
B382S28531040Surgical Direct - 4" Tennant Tying Forceps, Straight, 19 mm Extra-Delicate Shafts, 6 mm Tying Platform, Round Handle, Longitudinal Serrations+1 (800) 519-3293info@surgicaldirect.com
B382S2853252T0Surgical Direct - 4 1/3" Giannetti MICS Capsulorhexis Forceps, Extra Delicate Vaulted Shanks, Vertical Vaulted Delicate Tips,+1 (800) 519-3293info@surgicaldirect.com
B382S285401100Surgical Direct - 4 3/8" Troutman Colibri Forceps, 0.12mm, 1 x 2 Teeth Angled at 45 Degrees, with Ergonomic Fenestrated Handle+1 (800) 519-3293info@surgicaldirect.com
B382SD902172106T0Surgical Direct - 7 1/8" Micro Forceps, Jaw Length 6.0mm, Diamond Dusted, with Tying Platform, with Counterw7 1/8" Micro Forceps, Jaw Length 6.0mm, Diamond Dusted, with Tying Platform, with Counterweight, with Pin, Titanium+1 (800) 519-3293info@surgicaldirect.com
B382SD9023191000Surgical Direct - 7 1/8" Ferris Smith Tissue Forceps 1 x 2 Teeth+1 (800) 519-3293info@surgicaldirect.com
B382SD9027351020Surgical Direct - 3 1/2" Bonn Forceps, 1 × 2 Teeth, Tip Width 0.12 mm, Titanium+1 (800) 519-3293info@surgicaldirect.com
B382SD9028531080Surgical Direct - Willis Hospital Utility Forceps, Straight, 15mm Serrated+1 (800) 519-3293info@surgicaldirect.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
606841101706611K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
606841434266412K932938ELMED ESU 300 M/M AND DIGITALGEI1994-05-02
606842013548300K926517ELMED LBC 50-PHIN1994-11-15
606841187916063K193018Surgical Direct Hand-held Laparoscopic InstrumentsGEI2019-12-20
606841379070890K143221Schoelly LaparoscopeGCJ2014-12-05
606841435362216K060899FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPEFAJ2007-03-02
606841057334251
606841118992287
606841129811196
606841136672915
606841146145149
606841175909180
606841208419267
606841432044063
606841433497894
606841434567059
606841449924004
606841476081973
606841538361007
606841566536028
606841623550960
606841637280835
606841679654519
606841687749123
606841778910249
606841780966275
606841801042599
606841874466769
606841952048412
606841998503601
606842073091049

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI22019-12-20
GCJ22014-12-05
FAJ12007-03-02
HIN11994-11-15

PMN#

GUDID#

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